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Infringement Food and Drug Administration (FDA)

Knobbe Martens

Skinny Labeling May Not Be Enough to Avoid Induced Infringement Allegations

Knobbe Martens on

Before Moore, Lourie, and Albright. Appeal from the United States District Court for the District of Delaware. Summary: The totality of the complaint’s allegations must be considered when assessing whether induced patent...more

WilmerHale

Federal Circuit Addresses Scope of Medical Device and Drug Infringement Safe Harbor

WilmerHale on

On March 25, 2024, the Federal Circuit issued an opinion in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., addressing whether the act of importing two heart valve systems for a medical conference was within the...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Device Developments of 2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more

MoFo Life Sciences

Skinny Labels Back In Focus After HHS Report On Addressing Drug Prices

MoFo Life Sciences on

Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l February 2020 #2

LEGISLATION, REGULATIONS & STANDARDS - France to Ban Mass Culling of Male Chicks - France’s agriculture minister has reportedly announced that the country will prohibit the mass culling of male chicks shortly after they...more

Pillsbury Winthrop Shaw Pittman LLP

Despite Amarin, ITC May Be Right Prescription For Pharma

Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more

Robins Kaplan LLP

Personalized Medicine and Patent Eligibility under 35 U.S.C. § 101

Robins Kaplan LLP on

Double-digit growth is predicted for the molecular diagnostic market in the next several years, driven in part by an increased demand for personalized medicine—medical decisions and therapeutic products tailored to address...more

Wilson Sonsini Goodrich & Rosati

Sandoz v. Amgen: Interpretation of the Biosimilar Act Results in Dismissal for Lack of Subject Matter Jurisdiction for Declaratory...

On November 11, 2013, the U.S. District Court for the Northern District of California in Sandoz, Inc. v. Amgen, Inc. and Hoffman-La Roche, Inc., Docket No. C-13-2904, made the first-ever judicial interpretation of the...more

Foley & Lardner LLP

Federal Circuit Finds LUNESTA Patent Infringement Based on ANDA Product Description Not Avoided by Other Certifications

Foley & Lardner LLP on

In Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reversed the district’s holding of no Lunesta® patent infringement that was based on a certification submitted to the court, and found...more

McDonnell Boehnen Hulbert & Berghoff LLP

Research Foundation of State University of New York v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2013)

When assessing the validity of a patent, you cannot ignore the dependent claims. That was the main takeaway from the recent Federal Circuit case, Research Foundation of State University of New York v. Mylan Pharmaceuticals...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Denies Certiorari in Momenta Case

The Supreme Court on Monday declined to grant certiorari in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, a case involving a split in authority that has arisen among Federal Circuit judges regarding the scope of the...more

Knobbe Martens

Federal Circuit Review - Volume 3 | Issue 5 - May 2013

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In This Issue: • Patent Office Must Prove Prior Art Reference Is Enabling • Complaint Was Adequate Despite Non-Infringing Possibilities • FDA Approval Not Relevant to Obviousness Analysis - Excerpt from...more

Fenwick & West LLP

Intellectual Property Bulletin Winter 2013: Murky Waters: Post-Approval Regulatory Activities and the § 271(e)(1) Safe Harbor

Fenwick & West LLP on

On January 14, 2013, the U.S. Supreme Court refused to consider the U.S. Court of Appeals for the Federal Circuit's exclusion in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), of post-approval...more

McDonnell Boehnen Hulbert & Berghoff LLP

MBHB Snippets: Review of Developments in Intellectual Property Law - Winter 2013 - Volume 11, Issue 1: Federal Courts Debate Safe...

Patent protection is a critical driver of value for the biotech industry. One of the unique aspects of biotech patents, however, is that many otherwise infringing activities are exempt from claims of patent infringement when...more

McDonnell Boehnen Hulbert & Berghoff LLP

MBHB Snippets: Review of Developments in Intellectual Property Law - Winter 2013 - Volume 11, Issue 1

In This Issue: Federal Courts Debate Safe Harbor Exemption for Patent Infringement Under 35 U.S.C. § 271(e) Following Merck v. Integra; If I Prioritize Examination of My Application, Should the Patent Office?;...more

McDonnell Boehnen Hulbert & Berghoff LLP

Top Stories of 2012: #4 to #7

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that...more

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